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Reducing Oral Bacteria in Intubated Patients with SwishKit

This study is looking at how well a device called SwishKit, when added to regular oral care, can reduce bacteria in the mouths of patients who are on a breathing machine (intubated) in the Intensive Care Unit (ICU). You might be able to join if you are an adult (18 years or older) and are intubated with a breathing tube, and are expected to remain intubated for at least two days. The study will compare patients who receive standard oral care to those who receive standard oral care plus the SwishKit. The main goal is to see how much bacteria is in the mouth within five days after joining the study. This is a small pilot study aiming to enroll 21 patients, and the current status is unclear.

Study design
This is a randomized pilot study with 21 participants. Participants will be assigned to either the standard oral care group or the SwishKit plus standard oral care group.
What's involved
You would receive either standard oral care or standard oral care with the SwishKit for up to five days, or until your breathing tube is removed.
Compensation
Not stated in the trial record.
Follow-up
Bacterial levels will be measured within five days after joining the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06193512

Efficacy of A Novel RinSe Device to Reduce Oral Bacteria in Intubated IntEnsive CaRe Patients: a Pilot Study

Active, Not Recruiting
NAAges 18+InterventionalPrevention
The Cleveland Clinic
~21 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:SwishKit + Oral care treatment as usualOral care treatment as usual

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Bacterial load in the oropharyngeal space
Measured over Within 5 days after enrolment.

Conditions

Oral Bacterial Infection
Mechanical Ventilation Complication

Explore related trials

Bacterial oral infectionMechanical Ventilation Complication

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Marcelo Gama de Abreu, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults, 18 years or older
Individual or legally authorized representative consent
Intubated with an oral endotracheal tube and expected to remain intubated for at least 2 days.

Exclusion

Maxillofacial trauma (current maxillofacial trauma precluding standard oral care techniques)
Conditions precluding lateral Trendelenburg positioning (e.g., increased intracranial pressure, spinal instability, hemodynamic instability)
Oropharyngeal injury or infection
Orofacial edema precluding access for oral care
Known or anticipated difficult intubation
Endotracheal cuff air leak that clinicians believe precludes mouth lavage
Already intubated for more than 24 continuous hours within a week before enrollment.

What this trial measures

  • Bacterial load in the oropharyngeal spaceWithin 5 days after enrolment.

    Incidence of the presence of bacterial load in the oropharyngeal space from culture and qPCR of the five target pathogens: Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter spp.